Abstract：
OBJECTIVE: To evaluate the accuracy of the Wellvii VitalDetect automated oscillometric finger blood pressure monitor (single cuff size) for self/home blood pressure measurement according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).
METHODS: According to the universal standard, a total of 92 participants were recruited and finally blood pressure of 85 eligible participants was sequentially measured and compared with a standard mercury sphygmomanometer.
RESULTS: A total of 255 comparison pairs were obtained and analyzed based on the universal standard. For the validation criterion 1 of the ISO 81060-2:2018 universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.66 ± 7.67 and 1.04 ± 6.45 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was ± 6.49 mmHg (pass ≤ 6.73 mmHg) and ± 5.67 mmHg (pass ≤ 6.86 mmHg) for systolic and diastolic blood pressure, respectively.
CONCLUSIONS: The Wellvii VitalDetect automated finger blood pressure monitor passed all the requirements for validation by the ISO 81060-2:2018 universal standard and can be recommended for self/home blood pressure measurement in general population.
METHODS: According to the universal standard, a total of 92 participants were recruited and finally blood pressure of 85 eligible participants was sequentially measured and compared with a standard mercury sphygmomanometer.
RESULTS: A total of 255 comparison pairs were obtained and analyzed based on the universal standard. For the validation criterion 1 of the ISO 81060-2:2018 universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.66 ± 7.67 and 1.04 ± 6.45 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was ± 6.49 mmHg (pass ≤ 6.73 mmHg) and ± 5.67 mmHg (pass ≤ 6.86 mmHg) for systolic and diastolic blood pressure, respectively.
CONCLUSIONS: The Wellvii VitalDetect automated finger blood pressure monitor passed all the requirements for validation by the ISO 81060-2:2018 universal standard and can be recommended for self/home blood pressure measurement in general population.
摘要：
目的：根据AAMI/ESH/ISO通用标准（ISO81060-2：2018），评估WellviiVitalDetect自动示波手指血压计（单个袖带尺寸）用于自我/家庭血压测量的准确性。
方法：根据通用标准，共招募了92名参与者,最后对85名符合条件的参与者依次测量血压,并与标准水银血压计进行比较.
结果：总共获得了255个比较对，并根据通用标准进行了分析。对于ISO81060-2：2018通用标准的验证标准1，对于收缩压和舒张压，测试设备和参考血压读数之间的差异的平均值±SD为1.66±7.67和1.04±6.45mmHg，分别。对于标准2，每个受试者的测试设备和参考血压之间的平均血压差的SD为±6.49mmHg（通过≤6.73mmHg）和收缩压和舒张压的±5.67mmHg（通过≤6.86mmHg）。分别。
结论：WellviiVitalDetect自动手指血压监测仪通过了ISO81060-2：2018通用标准的所有验证要求，可推荐用于普通人群的自我/家庭血压测量。
方法：根据通用标准，共招募了92名参与者,最后对85名符合条件的参与者依次测量血压,并与标准水银血压计进行比较.
结果：总共获得了255个比较对，并根据通用标准进行了分析。对于ISO81060-2：2018通用标准的验证标准1，对于收缩压和舒张压，测试设备和参考血压读数之间的差异的平均值±SD为1.66±7.67和1.04±6.45mmHg，分别。对于标准2，每个受试者的测试设备和参考血压之间的平均血压差的SD为±6.49mmHg（通过≤6.73mmHg）和收缩压和舒张压的±5.67mmHg（通过≤6.86mmHg）。分别。
结论：WellviiVitalDetect自动手指血压监测仪通过了ISO81060-2：2018通用标准的所有验证要求，可推荐用于普通人群的自我/家庭血压测量。
